Changes included in the ISO/DIS 9001:2026 Quality management systems – Requirements

November 12, 2025

ISO 9001:2026 – Key Changes You Need to Know

Clause 3: Terms and Definitions

• Specific QMS-related terms will be included directly in the standard.Emphasize: review of definitions.
• Emphasize: review of definitions.

Clause 4: Context of the Organization

• Climate change that was introduced in previous amendment remains and shall be evaluated as a potentially relevant issue for the organization. 
• Climate change may be a requirement of an interested party.
• Strategic direction and resource allocation are important factors to consider in the organization’s internal issues
• Emphasize: Confirm that climate change considerations are fully accounted for within your current management system and business context assessment.

Clause 5: Leadership

• Quality culture, continual improvement and ethical behavior will be introduced as ways that top management demonstrates leadership and commitment with respect to QMS.
• Emphasize: Quality culture and ethical behavior practices shall be adopted by the organization.

Clause 6: Planning

• Risks and opportunities will be restructured into two separate sub-clauses. Determining and managing risks and opportunities are separate processes. Risks are not opportunities. Opportunities result from assessment of the internal and external context including interested parties.
• Risks during or after a disruption may also be considered and appropriate countermeasures determined and applied.
• For planning of changes organizations shall consider the availability of information along with the availability of resources.
• Emphasize: Analyze how risks and opportunities are recognized, prioritized, and mitigated or leveraged in planning activities.

Clause 7: Support

• Personnel working under organizational control shall be aware of the quality culture and ethics of the organization.
• Emphasize: Prepare to refresh awareness training to include quality culture and ethics.

Clause 8: Operation

• Control of production and service provision through product and service verification or process validation or both is now introduced as a method of achievement.
• The organization shall now inform the external providers about the additional requirements they shall follow in case of interaction with its customers and other relevant interested parties.
• Emphasize: References to the standard must align with the updated paragraph structure

Clause 9: Performance Evaluation

• No major changes. Management review outputs are now management review results.
• Emphasize: confirm audit objectives and review criteria to meet the new requirements of the paragraphs

Clause 10: Improvement

• As part of the continual improvement, except for the management review results, the organization shall also consider the results of monitoring, and measurement, analysis and evaluation of data and information. It is also defined that Improvement can be achieved through incremental or breakthrough change, innovation or reorganization.
• Emphasize: leadership influences on improvement cycles.

The mentioned timeline is indicative, and deviations may occur. The revision process is scheduled to last a total of 36 months and is coordinated by the international technical committee ISO/TC 176 SC2 WG29